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Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women

Primary Purpose

Trauma

Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Visiospatial Interference
Sponsored by
University of Iceland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Intrusive memories

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Having experienced at least one criterion A trauma according to the DSM-5
  • Having at least one intrusive memory that occurs at least three times per week in the past four weeks
  • Being able to attend 3-8 sessions with researcher
  • Being willing to monitor intrusive memories in daily life
  • Having access to a smartphone
  • Being able to speak Icelandic and read study materials in Icelandic

Exclusion Criteria:

  • Current psychotic disorder (determined by the psychotic module on the Mini International Neuropsychiatric Interview (MINI)).
  • Current manic episode (determined by the bipolar module on the Mini International Neuropsychiatric Interview (MINI)).
  • Being acutely suicidal (according to the module assessing suicidality on the Mini International Neuropsychiatric Interview (MINI)).

Sites / Locations

  • University of Iceland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trauma exposed women

Arm Description

No Intervention: Baseline phase ('A'): Measurements collected in a daily diary four times a day (morning, afternoon, evening and night) over one week for the primary outcome (occurrence of intrusive memories of trauma). Individual baseline phases will be used as control periods. Experimental: Intervention phase ('B'): A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game-play with mental rotation) followed by instructions to engage in the task self-guided over the subsequent week. Measurements collected in a daily diary four times a day following the intervention for the primary outcome (occurrence of intrusive memories of trauma). Intervention: Behavioral: Brief cognitive intervention

Outcomes

Primary Outcome Measures

Change in the number of intrusive memories of trauma
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for one week during the baseline phase and each week during the intervention phase (week 1-6) and during one week at one month follow-up and three month follow-up.

Secondary Outcome Measures

Self-guided intervention adherence - usage of the gameplay intervention in daily life
How often did you manage to play Tetris after you experienced an intrusive memory? (11-point scale; 0 = not at all; 10 = every time).
Feasibility and acceptability ratings for using a smartphone game-play intervention
Feasibility and Acceptability of the intervention assessed with two self-rated items, "Would you recommend playing Tetris to a friend?" and "Do you consider gameplay to be an acceptable way to reduce the daily frequency of intrusive memories?". Scores could range from 0 - 10 with higher scores indicating greater acceptability/feasibility.
Feasibility and acceptability - open ended questions
Two open-ended questions: 1. "How did you feel about playing Tetris after you had an intrusive memory?" 2. "Did you find the intervention helpful? If yes, how?"
Impact of intrusive memories on concentration, sleep and stress - ratings
Six self-rated items to assess the impact of intrusive memories on concentration, sleep, and stress in the past week. 2 items assessing concentration difficulties in general and due to intrusive memories (11-point scale; high scores indicating more difficulties). 2 items assessing sleep disturbances due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance); and 1 item assessing to what degree intrusive memories affected stress levels (0 = not at all; 10 = affected very much).
Rating of how long intrusive memories disrupted concentration on average
1 item assessing for how long intrusive memories disrupted concentration on average on a 6-point scale (0 = <1 minute - 6 = > 60 minutes)
General impact of intrusive memories - ratings
Two items both rated on an 11-point scale: 1. "During the last week, how distressing were your intrusive memories (0 = not at all; 10 = very distressing). 2. During the last week, how vivid were your intrusive memories (0 = not at all; 10= very vivid)
Intrusion diary adherence
Adherence to the intrusion diary assessed with 1 item: "How accurately did you fill out the diary?" (0= not at all; 10 = very accurately)
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
The PCL-5 is a short 20-item self-report scale used to assess the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD. Symptoms are rated from 0-4. Higher scores indicate greater severity.
The Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item self-report measure of depression symptoms and the severity of those symptoms. Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
The Generalized Anxiety Disorder-7 scale (GAD-7)
The GAD-7 is a brief self-report questionnaire designed as a screening tool for symptoms of general anxiety disorder and their severity. Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
The Sheehan Disability Scale (SDS)
The SDS is a self-report questionnaire which is designed to assess functional impairment across three domains: (1) Work/school, (2) social, and (3) family life. These domains are measured on an 11-point scale which ranges from 0 (i.e., not at all) to 10 (i.e., extremely). The scale will be adjusted to assess impairment associated with intrusive memories.
Impact of intrusive memories on functioning
Two questions assessing the impact intrusive memories have on functioning in daily life. One question is open-ended: "Have the intrusive memories affected your ability to function in your daily life in the past week? If yes, how?" and one question is self-rated: "Have the intrusive memories affected your ability to function in your daily life?" (11-point scale, higher score indicate greater impact on functioning.)

Full Information

First Posted
April 8, 2020
Last Updated
September 30, 2021
Sponsor
University of Iceland
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1. Study Identification

Unique Protocol Identification Number
NCT04342416
Brief Title
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Official Title
Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iceland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is an extension on a study already preregistered NCT04209283 and is designed to investigate the use of a simple cognitive task (a memory cue followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. This is a single case series using a within subject multiple baseline AB design. Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue using the technique self-guided in subsequent weeks. Participants will be asked to monitor the occurrence of intrusive memories of trauma in a daily diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase and that the frequency of targeted intrusive memories is going to decrease relative to non-targeted intrusive memories. Furthermore, the investigators will explore whether having fewer intrusive memories has an impact on function and/or PTSD, depressive or anxiety symptoms.
Detailed Description
Participants will attend 3-8 sessions with researchers and sessions will be conducted remotely via telephone or secure video platform (Kara Connect). In session one, the intrusive memories will be logged for monitoring their frequency in a daily diary for the following weeks. Baseline assessment questionnaires will also administered. In the second session, a memory will be selected and targeted with the intervention (memory reminder followed by 25 min gameplay with mental rotation) followed by monitoring the frequency of both the targeted and non-targeted intrusive memories. Participants will also complete self-rated questions concerning the impact of their intrusive memories. The intervention session will be repeated for other intrusive memories (maximum 6 intervention sessions). In the last intervention session, participants will be asked to complete questionnaires and self-rated questions assessing the impact of their intrusive memories. Participants will be asked to complete measures at 1 month follow-up and at 3 month follow-up. In the 1 month follow-up and the 3 month follow-up, participants complete questionnaires and monitor the frequency of intrusive memories for one week. The investigators note that the intended timeframes (e.g. one-week for baseline and one-week for intervention phase) may differ slightly across participants depending on availability and the practicalities of remote delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
Intrusive memories

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma exposed women
Arm Type
Experimental
Arm Description
No Intervention: Baseline phase ('A'): Measurements collected in a daily diary four times a day (morning, afternoon, evening and night) over one week for the primary outcome (occurrence of intrusive memories of trauma). Individual baseline phases will be used as control periods. Experimental: Intervention phase ('B'): A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game-play with mental rotation) followed by instructions to engage in the task self-guided over the subsequent week. Measurements collected in a daily diary four times a day following the intervention for the primary outcome (occurrence of intrusive memories of trauma). Intervention: Behavioral: Brief cognitive intervention
Intervention Type
Behavioral
Intervention Name(s)
Visiospatial Interference
Intervention Description
Behavioral: Brief cognitive intervention. A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) with instructions to engage in the task self-guided in the subsequent weeks.
Primary Outcome Measure Information:
Title
Change in the number of intrusive memories of trauma
Description
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for one week during the baseline phase and each week during the intervention phase (week 1-6) and during one week at one month follow-up and three month follow-up.
Time Frame
Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
Secondary Outcome Measure Information:
Title
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Description
How often did you manage to play Tetris after you experienced an intrusive memory? (11-point scale; 0 = not at all; 10 = every time).
Time Frame
Intervention week 2-6
Title
Feasibility and acceptability ratings for using a smartphone game-play intervention
Description
Feasibility and Acceptability of the intervention assessed with two self-rated items, "Would you recommend playing Tetris to a friend?" and "Do you consider gameplay to be an acceptable way to reduce the daily frequency of intrusive memories?". Scores could range from 0 - 10 with higher scores indicating greater acceptability/feasibility.
Time Frame
Post intervention up to week 7
Title
Feasibility and acceptability - open ended questions
Description
Two open-ended questions: 1. "How did you feel about playing Tetris after you had an intrusive memory?" 2. "Did you find the intervention helpful? If yes, how?"
Time Frame
Post intervention up to week 7
Title
Impact of intrusive memories on concentration, sleep and stress - ratings
Description
Six self-rated items to assess the impact of intrusive memories on concentration, sleep, and stress in the past week. 2 items assessing concentration difficulties in general and due to intrusive memories (11-point scale; high scores indicating more difficulties). 2 items assessing sleep disturbances due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance); and 1 item assessing to what degree intrusive memories affected stress levels (0 = not at all; 10 = affected very much).
Time Frame
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Title
Rating of how long intrusive memories disrupted concentration on average
Description
1 item assessing for how long intrusive memories disrupted concentration on average on a 6-point scale (0 = <1 minute - 6 = > 60 minutes)
Time Frame
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Title
General impact of intrusive memories - ratings
Description
Two items both rated on an 11-point scale: 1. "During the last week, how distressing were your intrusive memories (0 = not at all; 10 = very distressing). 2. During the last week, how vivid were your intrusive memories (0 = not at all; 10= very vivid)
Time Frame
Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
Title
Intrusion diary adherence
Description
Adherence to the intrusion diary assessed with 1 item: "How accurately did you fill out the diary?" (0= not at all; 10 = very accurately)
Time Frame
Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
Title
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Description
The PCL-5 is a short 20-item self-report scale used to assess the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD. Symptoms are rated from 0-4. Higher scores indicate greater severity.
Time Frame
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Title
The Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a 9-item self-report measure of depression symptoms and the severity of those symptoms. Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Time Frame
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Title
The Generalized Anxiety Disorder-7 scale (GAD-7)
Description
The GAD-7 is a brief self-report questionnaire designed as a screening tool for symptoms of general anxiety disorder and their severity. Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Time Frame
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Title
The Sheehan Disability Scale (SDS)
Description
The SDS is a self-report questionnaire which is designed to assess functional impairment across three domains: (1) Work/school, (2) social, and (3) family life. These domains are measured on an 11-point scale which ranges from 0 (i.e., not at all) to 10 (i.e., extremely). The scale will be adjusted to assess impairment associated with intrusive memories.
Time Frame
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Title
Impact of intrusive memories on functioning
Description
Two questions assessing the impact intrusive memories have on functioning in daily life. One question is open-ended: "Have the intrusive memories affected your ability to function in your daily life in the past week? If yes, how?" and one question is self-rated: "Have the intrusive memories affected your ability to function in your daily life?" (11-point scale, higher score indicate greater impact on functioning.)
Time Frame
Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having experienced at least one criterion A trauma according to the DSM-5 Having at least one intrusive memory that occurs at least three times per week in the past four weeks Being able to attend 3-8 sessions with researcher Being willing to monitor intrusive memories in daily life Having access to a smartphone Being able to speak Icelandic and read study materials in Icelandic Exclusion Criteria: Current psychotic disorder (determined by the psychotic module on the Mini International Neuropsychiatric Interview (MINI)). Current manic episode (determined by the bipolar module on the Mini International Neuropsychiatric Interview (MINI)). Being acutely suicidal (according to the module assessing suicidality on the Mini International Neuropsychiatric Interview (MINI)).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andri Björnsson, PhD
Organizational Affiliation
University of Iceland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iceland
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland

12. IPD Sharing Statement

Plan to Share IPD
No

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Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women

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